The Lead Device Supplier Relationship Manager manages supplier relationships within the DCP organization to achieve Takeda s objectives and in close coordination and collaboration with Procurement, Tech Ops OpU SRMs (for Combination Products) to achieve Takeda s objectives:
- Lead the day to day business relationship between our external suppliers and internal team members both within and outside of our PDTS group
- Lead and be accountable for supplier agreements and contracts such as CDA, NDA, MSA, SOW, Quality agreement, and other supplier agreements
- Follow business processes and guidelines to act as the center of excellence for legal and financial aspects of the alliance
- Contribute to negotiation of contract terms and conditions, including the management of amendment activities.
- Contribute to tactical and strategic sourcing activity identifying and selecting strategic partners
- Prepare and facilitate proper meeting cadence with suppliers such as quarterly business review, JSC, and other meetings as appropriate
- Work closely with technical teams and manage supplier issue escalation and addressing obstacles
- Develop and monitor KPI, generate monthly reports, track issues
- Manage multiple scopes of work in support of the medical device objectives
- Ability to travel domestically and internationally up to 40+%
- Lead and be accountable to CDA, NDA, MSA, SOW, Quality agreement, and supplier agreements
- Work with cross functional technical team to develop and monitor short-term and long-term plans, including timelines, forecasts, for achieving department strategies.
- Partner with Takeda stakeholders to select among existing or develop new CMOs who can meet program requirements and augment Takeda internal or external manufacturing network capabilities
- Manage existing supplier business relationships, including proper meeting cadence
- Conduct make vs Buy analyses with the cross functional team and DPL, as needed
- Develop and strengthen mutually beneficial relationships with members of Takeda's CMO network (Procurement, OpU SRMs for Combination Products)
- Coordinate with Tech Ops OpU SRM to convey device priority and planning
- Work with peer groups to develop targets for the suppliers' KPI dashboards working with the cross functional team
- Monitor performance of the suppliers and serve as primary point of escalation for issues/KPIs.
- Review KPIs with suppliers and internal teams (consider customer survey)
- Participate in the implementation of CAPAs. Communicate changes and issues with suppliers
- Participate in major projects to improve supplier performance and continuous improvement projects
- Track, monitor, and report performance metrics related to operations, quality, cost, and customer service. Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.
- Clinical and commercial device planning (logistics, ordering, challenges, proactive plans)
- Work with other DPL s to ensure that technology, operations, and quality expectations are accurately represented in requests for proposals, and then reflected in subsequent contracts and agreements with CMO's.
- Proactively identify CMO activity-related risks that may impact Takeda program commitments: supply delivery dates, program milestones, or goals. Work with CMOs, DPLs and cross-functional business partners to develop robust mitigation and contingency plans.
- Identify, elevate, and work with Takeda stakeholders and CMO's to facilitate resolution of issues that may arise.
- Monitor and work to ensure that Takeda's expectations and goals for regulatory compliance, product quality, and production (e.g. cost, cycle-times, yield, etc.) are consistently met for the programs
- Monitor and drive adherence to Takeda's and CMO contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally.
- Supports implementation of Continuous Improvement initiatives (including Lean Sigma) at suppliers/CMO's
- Participate in lesson learned reviews at least at the following milestone achievements:
- Contract signed
- Feasibility assessment competed
- Regulatory filling readiness
- 1st Launch (1st major geography US, EU)
- Performs other assignments as requested by the DCP leadership team
- Comply with appropriate legislation and Takeda policies including, but not limited to: Sarbanes Oxley, Environmental Safety & Health, and Corporate Responsibility
Education and Experience Requirements
- Bachelor/ Master Degree in Engineering, Biotechnology, Business or scientific field
- Minimum of 12 years relevant clinical/commercial Pharmaceutical experience
- Strong business development, project management, problem solving, decision making, collaboration, influence, and facilitation skills.
- Experience leading cross-functional teams to overcome hurdles and deliver project results on time and as expected.
- Interpersonal skills necessary to develop effective working relationships with internal stakeholders, CMOs, and represent the External manufacturing organization on cross-functional and cross-cultural project teams.
- Understanding of biotech/pharma manufacturing operations, product and process development, and supply chain operations
- Ability to effectively communicate and persuade others at every level to accomplish challenging tasks
- Demonstrable cGMP Manufacturing knowledge working in a cGMP manufacturing environment
- Knowledge in FDA & EU device/combination product development requirements
- Able to negotiate and manage contracts
- Experienced in risk management processes
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.